Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced Hand-foot Syndrome

NCT01609166 | Completed Phase 2 DMC

• 2 other identifiers: IIB-ALO-2010-022010-022095-31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial is conducted on the basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS. A randomized, double-blind phase III trial will evaluate 40 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be applied to the hands and feet twice per day for 6 months after the start of capecitabine. Patients will be examined every month and the investigators will take some photographs of hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events \[CTCAE\]v3.0) will be also collected at baseline and at the end of each cycle. The primary end point is the incidence of moderate/severe HFS symptoms at the end of capecitabine treatment , based on the patient-reported dermatological exploration.

Conditions

Hand-foot Syndrome

Keywords

Hand-foot Syndrome; capecitabine; allopurinol

Outcome Measures

Primary Outcomes (1)

• Changes in the signs of hand-foot syndrome

  Erythema, descamation, vesiculation

  At 1-2-3-4-5-6 months

Secondary Outcomes (1)

• Changes in the symptoms of hand-foot syndrome

  At 1-2-3-4-5-6 months

Study Arms (2)

Allopurinol 3% cream

EXPERIMENTAL

Allopurinol 3% cream in one side of the body

Drug: Allopurinol

Placebo cream

PLACEBO COMPARATOR

Placebo cream in the other side of the body

Drug: Placebo

Interventions

Allopurinol DRUG

Allopurinol 3% cream application in one side of the body, twice a day for 6 months

Allopurinol 3% cream

Placebo DRUG

Placebo cream application in the other side of the body, twice a day for 6 months

Placebo cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18years-old,that initiate treatment with oral capecitabine, without signs of hand-feet syndrome toxicity.
• Free acceptance to participate part in this clinical trial, with signature of the form of informed assent approved for the study, writing of the volunteer.

You may not qualify if:

• Age lower than 18 years
• Precedents of allergy, idiosyncrasy or hypersensitivity to the medicament.
• Denial of the patient to sign the informed assent.
• Any disorder or current / previous treatment that, in the opinion of the investigator, incapacitates the patient to take part in the study.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 31, 2012
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

ES (1)